Number and percentage of patients reporting prespecified MTX-related AEs during study by treatment group, n (%)
| MTX weekly dosage | CONCERTO | MUSICA | ||||||
| 2.5 mg (n=98) | 5 mg (n=100) | 10 mg (n=99) | 20 mg (n=98) | Overall (n=395) | 7.5 mg (n=154) | 20 mg (n=155) | Overall (n=309) | |
| Infection | 6 (6.1) | 7 (7.0) | 11 (11.1) | 13 (13.3) | 37 (9.4) | 11 (7.1) | 20 (12.9) | 31 (10) |
| Nausea and/or vomiting | 6 (6.1) | 3 (3.0) | 13 (13.1) | 8 (8.2) | 30 (7.6) | 9 (5.8) | 12 (7.7) | 21 (6.8) |
| Stomach pain/discomfort | 5 (5.1) | 4 (4.0) | 7 (7.1) | 7 (7.1) | 23 (5.8) | 5 (3.2) | 5 (3.2) | 10 (3.2) |
| Abnormal hair loss | 1 (1.0) | 5 (5.0) | 5 (5.1) | 8 (8.2) | 19 (4.8) | 9 (5.8) | 3 (1.9) | 12 (3.9) |
| Unexplained diarrhoea | 1 (1.0) | 3 (3.0) | 6 (6.1) | 2 (2.0) | 12 (3.0) | 2 (1.3) | 6 (3.9) | 8 (2.6) |
| Excessive fatigue/malaise | 4 (4.1) | 1 (1.0) | 3 (3.0) | 2 (2.0) | 10 (2.5) | 4 (2.6) | 1 (0.6) | 5 (1.6) |
| Dizziness | 4 (4.1) | 0 | 4 (4.0) | 1 (1.0) | 9 (2.3) | 5 (3.2) | 3 (1.9) | 8 (2.6) |
| Skin rash and/hives | 1 (1.0) | 3 (3.0) | 3 (3.0) | 2 (2.0) | 9 (2.3) | 3 (1.9) | 4 (2.6) | 7 (2.3) |
| Oral ulcers | 0 | 1 (1.0) | 5 (5.1) | 2 (2.0) | 8 (2.0) | 3 (1.9) | 5 (3.2) | 8 (2.6) |
| Abnormal sweating | 1 (1.0) | 1 (1.0) | 1 (1.0) | 0 | 3 (0.8) | 3 (1.9) | 1 (0.6) | 4 (1.3) |
| Fever and/or chills | 0 | 1 (1.0) | 3 (3.0) | 0 | 4 (1.0) | 2 (1.3) | 3 (1.9) | 5 (1.6) |
| Chronic dry cough | 0 | 1 (1.0) | 1 (1.0) | 1 (1.0) | 3 (0.8) | 1 (0.6) | 1 (0.6) | 2 (0.6) |
| Unexplained visual changes | 0 | 0 | 2 (2.0) | 1 (1.0) | 3 (0.8) | 1 (0.6) | 0 | 1 (0.3) |
| Conjunctivitis | 0 | 0 | 0 | 2 (2.0) | 2 (0.5) | 0 | 2 (1.3) | 2 (0.6) |
| Skin pigment changes | 0 | 0 | 1 (1.0) | 1 (1.0) | 2 (0.5) | 0 | 0 | 0 |
| Unintended weight loss | 1 (1.0) | 1 (1.0) | 0 | 0 | 2 (0.5) | 0 | 0 | 0 |
| Nose bleed | 1 (1.0) | 0 | 0 | 0 | 1 (0.3) | 0 | 0 | 0 |
| Tinnitus | 0 | 0 | 0 | 1 (1.0) | 1 (0.3) | 0 | 0 | 0 |
| Total number of patients with MTX-related AEs | 19 (19.4) | 22 (22) | 36 (36.4) | 36 (36.7) | 113 (28.6) | 32 (20.8) | 39 (25.2) | 71 (23.0) |
AE, adverse event; MTX, methotrexate.